(223 days)
The TechLab Crypto-Cel IF Test can be used to detect Cryptosporidium oocysts in fecal specimens from persons suspected of having intestinal disease due to this pathogen.
The kit, which includes ready-to-use reagents, contains an antibody reagent consisting of FITC-labeled anti-Cryptosporidium monoclonal antibody. This antibody functions as the detecting antibodies. The monoclonal antibody is prepared from mouse ascites fluid.
This document describes a diagnostic test for detecting Cryptosporidium oocysts in fecal specimens. As such, concepts like "AI," "machine learning," "training sets," "test sets," "ground truth," "MRMC studies," and "adjudication methods" are not applicable in their typical sense. Instead, the study evaluates the performance of a new diagnostic device against existing, approved diagnostic methods.
Here's an interpretation of the provided text in the context of diagnostic device evaluation, addressing the requested categories where feasible:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of specific "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy is not explicitly stated with numerical targets in the provided text. Instead, the primary acceptance criterion appears to be demonstrating substantial equivalence to an already approved immunofluorescent test.
The performance is reported as a correlation rather than traditional diagnostic accuracy metrics.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to an approved immunofluorescent test. | 100% correlation with Merifluor Cryptosporidium/Giardia Direct IF Test. |
| 100% correlation with Crypto/Giardia-Cel IF Test (510(k) application submitted). | |
| Usefulness for detection of Cryptosporidium in fecal specimens. | Demonstrated by 100% correlation with established tests. |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample sizes for the "two studies" are not provided in the text. The data provenance (country of origin, retrospective/prospective) is also not specified. The studies are clinical evaluations comparing the new test to existing ones, implying they involved fecal specimens from persons suspected of having intestinal disease.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The concept of "experts establishing ground truth" in the AI sense is not directly applicable here. The "ground truth" for the performance comparison is established by existing, approved diagnostic tests themselves. Therefore, human experts did not "establish" the ground truth for this specific study in the way they might annotate images for an AI. The experts involved would be the laboratory personnel performing and interpreting the reference immunofluorescent tests. Their qualifications are not specified.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1 or 3+1) are typically used to resolve discrepancies among multiple human readers or between human readers and an AI. Since the comparison is between two laboratory assays, no human adjudication method in this sense would be used. The "truth" is determined by the results of the reference assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human performance. The provided text describes a direct comparison between two diagnostic assays, not an AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, a "standalone" performance was evaluated. The Crypto-Cel IF Test is a laboratory assay that produces a result (detection of oocysts). Its performance was assessed independently by comparing its results to those of other established laboratory assays. There is no "human-in-the-loop" performance in the AI context; the test itself is the "algorithm" and its output is compared.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for evaluating the Crypto-Cel IF Test was established by the results of existing, approved immunofluorescent diagnostic tests (Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure and Crypto/Giardia-Cel IF Test). These tests themselves are considered the standard for detecting Cryptosporidium oocysts in fecal specimens.
8. The Sample Size for the Training Set
There is no training set in this context. The Crypto-Cel IF Test is a traditional immunofluorescent assay, not an AI model that undergoes a training phase.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this question is not applicable.
§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.